510(k) · Cleared
ClearedMediled Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medix I.C.S.A. · LBI Unit, Neonatal Phototherapy
Cleared on Aug 15, 2011 as substantially equivalent to K022196 (Natus Medical, Inc., 2002) and 1 other predicate after a 236-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Aug 15, 2011
- Review
- 236 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940996 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 2 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 1 generation backK083179 Mediled Phototherapy LampMedix I.C.S.A. · 2009
- This deviceK103735 Mediled MiniMedix I.C.S.A. · 2011
- Descendant · cites it directly · 0 of its ownK160745 neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated · 2016
Most influential descendants
Showing 1 of 1 · See all- K160745neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −2 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −1 | K083179 | Mediled Phototherapy Lamp | Medix I.C.S.A. | 2009 | — |
| 0 (this device) | K103735 | Mediled Mini | Medix I.C.S.A. | 2011 | — |
| +1 | K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LBI device
- #1 K251308 SnugLit (TM) Wearable Phototherapy System…score 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 1…de. LBI 3. Predicate Devices: The MediLEDmini Phototherapy Lamp is substantially equivalent to the Natus Blue Light Phototherapy Unit [K022196] and the Medix MediL-ED Phototherapy Unit [K0831 79]. 4. Intended Use Statement: INDICATIONS FOR USE: Th… | 2002 |
| * | K083179 | Mediled Phototherapy LampSummary page 1…The MediLEDmini Phototherapy Lamp is substantially equivalent to the Natus Blue Light Phototherapy Unit [K022196] and the Medix MediL-ED Phototherapy Unit [K0831 79]. 4. Intended Use Statement: INDICATIONS FOR USE: The MediL-ED Phototherapy Lamp is intended for the tre… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160745 | neoBLUE compact LED Phototherapy System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K160745 (Natus Medical Incorporated, 2016) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K022196.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LBI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBI
134in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBI
3in 2025
MAUDE reports naming product code LBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 91 | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 1 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 3 | 157 | 0 | 5 |
| 2012 | 5 | 108 | 0 | 3 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 5 |
| 2015 | 1 | — | 1 | 6 |
| 2016 | 3 | 134 | 2 | 22 |
| 2017 | 2 | — | 0 | 577 |
| 2018 | 2 | — | 0 | 37 |
| 2019 | 1 | — | 1 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medix MediLEDmini Phototherapy Lamp is intended for the treatment of neonatal hyperbilirubinemia. The device can be used with infants in a bassinet, incubator, open bed or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103735: Mediled Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103735
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026